510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200898Substantially Equivalent

Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin

Medicon Hellas SA, Gerakas, GR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200898 is the FDA 510(k) clearance record for Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin, a class II device, cleared for Medicon Hellas S.A on under FDA product code CIX (Bromcresol Green Dye-Binding, Albumin). FDA records list 3 510(k) clearances for Medicon Hellas S.A, from to . As of , FDA records show no recalls naming K200898.

Clearance record

Decision date
Received
(536 days to decision)
Product code
CIX Bromcresol Green Dye-Binding, Albumin
Regulation
21 CFR 862.1035
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Medicon Hellas S.A Melitona 5-7, Gerakas, GR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CIX

Trailing 12 months
1 clearance under product code CIX in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CIX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260